Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Steady state area under the concentration time curve (AUC) between 0 and 12 hours of zidovudine (ZDV)-MP, ZDV-TP, and dTTP in PBMCs from HIV and hepatitis C virus (HCV) coinfected patients before and after peginterferon alfa-2b with or without ribavirin [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Systemic exposure (AUC over 0 to 12 hours) of nelfinavir before and after peginterferon alfa-2b with or without ribavirin in HIV and HCV coinfected patients [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48

Drug: Ribavirin plus interferon alfa-2b

Oral tablets taken daily

Drug: Ribavirin

Oral tablet taken daily

Drug: Peginterferon alfa-2b

Subcutaneous injection

Detailed Description:

An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin.

Participants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.

Eligibility

Ages Eligible for Study:

21 Years to 60 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

HCV-infected

HIV-1 infection

CD4 cell count > 200 cells/mm³ within 30 days prior to study entry

HIV RNA < 400 copies/ml within 90 days of study entry

Use of zidovudine, lamivudine, and any PI and/or NNRTI

ANC value >= 1,500 ml³ within 30 days of study entry

Weight > 50 kg (110 lbs) for women and > 60 kg (132 lbs) for men

Acceptable methods of contraception

Ability and willingness to complete the Baseline Adherence Questionnaire

Documentation of adherence confirmed by the Baseline Adherence Questionnaire and certified by the study officials

Exclusion Criteria

Previous ribavirin therapy

More than 2 months of interferon therapy

Current use of any NRTI other than ZDV and 3TC

Hepatitis B surface antigen positive

Infectious, autoimmune, tumoral, biliary, or vascular liver disease

Alcohol consumption of more than 50 g/day

Current use of intravenous drugs

Hemoglobin levels < 10 gm/dl

Methadone use

Chemotherapy

Certain medications

Acute opportunistic or bacterial infection requiring therapy at the time of enrollment

Hemoglobinopathy (e.g., thalassemia) or any other cause of tendency to hemolysis

Significant coronary diseases or two or more risk factors for coronary diseases, such as > 55 years old, hypertension, and cholesterol > 250 mg/dl

Any clinically significant diseases (other than HIV and HCV infection) that, in the opinion of study officials, would compromise the outcome of this study

Pregnancy

Participation in blinded clinical trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059358